SOURCES SOUGHT
Q -- Accuracy of the New Diagnostic Code to Identify Primary Sclerosing Cholangitis in Archived Electronic Health System Data
- Notice Date
- 6/27/2024 2:38:41 PM
- Notice Type
- Sources Sought
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95024Q00388
- Response Due
- 7/12/2024 7:00:00 AM
- Archive Date
- 07/27/2024
- Point of Contact
- Fred Ettehadieh
- E-Mail Address
-
Fred.Ettehadieh@nih.gov
(Fred.Ettehadieh@nih.gov)
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. Background and Objectives: �Primary sclerosing cholangitis (PSC) presents as an autoimmune cholangiopathy causing fibroinflammatory damage to the biliary tree, precipitating multifocal fibrotic biliary strictures. The underlying pathophysiology of PSC remains elusive, with prevailing theories implicating intricate interactions between environmental factors and dysregulated immune responses. This interplay potentially involves compromised defense mechanisms against bile acid injury, an exaggerated immune response to microbial triggers, and perturbations in gut microbiota, all contributing to the chronic injury of bile ducts. The consequential cholestatic liver damage often culminates in end-stage liver disease. Notably, PSC is commonly asymptomatic at onset and is often incidentally diagnosed through routine blood tests revealing a cholestatic liver profile. Importantly, individuals with PSC face an escalated risk of developing malignancies, including cholangiocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, and gallbladder cancer. Health administrative databases house extensive, routinely collected real-world health data that can be used for conducting disease epidemiology, outcomes research, healthcare cost/utilization trends analysis, and other healthcare investigations. Unfortunately, research on PSC using these resources was hampered by the lack of a PSC-specific ICD code until the introduction of the ICD-10 code for PSC in 2019, which standardized diagnostic codes, facilitating research opportunities. Before the introduction of a dedicated ICD-10 code in 2019 (K83.01), cases were often miscoded under general or unrelated liver conditions, which may have skewed previous studies and healthcare resource allocation. However, the accuracy of the PSC-specific ICD code has not been evaluated. Project requirements: �Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed.� The objectives of the requirements are: �The contractor shall review electronic health records to validate the PSC diagnosis. TASK 1 � OBTAIN INSTITUTIONAL APPROVALS AND DATASETS - The Contractor shall obtain approvals from the relevant institutional review board (IRB) and other institutional officials, if required. The Contractor shall obtain approval, for extracting relevant data from computerized databases and preparing analytic files suitable for epidemiologic research. All data will be queried from the hospital database. These data will include clinical diagnoses, procedures, medications, and other data elements. The Contractor shall be the sole party responsible for communications with any IRB or other institutional officials and shall regularly communicate the status of the approval process to the Government. TASK 2 � ESTABLISH TARGET SAMPLES AND CREATE PROTOCOL FOR REVIEW - The Contractor shall work in collaboration with the NIA to identify records for review and create a case report form (CRF). Discussions regarding the selection of variables and the formatting of data collection are also required. TASK 3 � CHART REVIEW AND CONSTRUCT DATASET - The Contractor shall examine the electronic health records of the targeted individuals to identify PSCs, adhering to the guidelines outlined in the created CRF. TASK 4 � CONDUCT ANALYSIS - The Contractor shall collaborate with the NIA to conduct the statistical analysis following the plan proposed by the NIA. The Contractor will provide a cloud-based platform to share the anonymized data for the NIA to access for analysis. TASK 5 � PREPARE REPORT - The Contractor shall collaborate with the NIA project officer to interpret the results and prepare a scientific report containing the methodology as well the aggregated results. There is no page limit for the document. Anticipated period of performance: 36 months from the date of the award. Capability statement /information sought: Small business concerns that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.� Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Small businesses must also provide their Company Name, Unique Entity ID (UEI) from SAM.gov, Physical Address, and Point of Contact Information. Interested small businesses are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2� x 11� paper size, with 1� top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirements and in the capability statement/information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. The response is limited to ten (10) pages.� The 10-page limit does not include the cover page, executive summary, or references, if requested. All capability statements sent in response to this Small Business Sources Sought Notice must be submitted to Fred Ettehadieh, Contracting Officer, by email at fred.ettehadieh@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Facsimile responses are not acceptable. �Disclaimer and Important Notes:� This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).�
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/9e71403f604e4f8b8d5caa7467d26ea1/view)
- Place of Performance
- Address: MD, USA
- Country: USA
- Country: USA
- Record
- SN07111364-F 20240629/240627230125 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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